Adasuve Approved for Agitation Associated with Schizophrenia or Bipolar I Disorder

ADASUVE (loxapine) 10mg inhalation powder by Alexza Pharmaceuticals

Alexza Pharmaceuticals announced that the FDA has approved Adasuve (loxapine inhalation powder) for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Adasuve is an anti-agitation product that combines loxapine, an antipsychotic, with Alexza's Staccato system that vaporizes the drug into small particle aerosol for inhalation, which allows for rapid onset of action.

The FDA approval is based on two Phase 3 trials that evaluated more than 1,600 patients. Clinical data showed Adasuve was found to be effective in the acute treatment of agitation in adults with schizophrenia or bipolar I disorder. In these two studies, Adasuve 10mg met the primary efficacy endpoint, with statistically significant reductions in agitation as compared to placebo at the two-hour post-dose time point, as well as the principal secondary endpoint. Adasuve also showed rapid effects in agitated patients, with statistically significant reductions in agitation apparent starting at 10 minutes following administration of a dose vs. placebo.

Adasuve will be available as single-use disposable inhalers containing 10mg loxapine in 5-unit cartons. It is expected to be available in the third quarter of 2013.